Quality - Quality Control Analyst
Holly Springs, NC US
Location: Holly Springs, NC (Onsite only)
Primary responsibilities for this position include performing tasks associated with USP/EP Compendia for GMP release of raw materials and drug product. The analyst will be responsible for ensuring that Seqirus samples are tested according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. Analyst may be required to perform or participate in tasks associated with method validation and transfers.
Analyst will be required to write change controls, raw material specifications, and perform minor project management work to maintain specifications.
Performs USP/EP testing for QC samples
Performs GMP testing and associated tasks without errors per applicable SOPs and protocols
Writes change controls, raw material specifications, and project manages changes related to raw material enrollment
Coordinates material shipments to third-party vendors
Serve as a liaison within multifunctional departments for testing requests.
Assist in laboratory and instrumentation onboarding
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
Participates and performs in cross-training to support staff availability within QC department
Develop expertise in assigned assays/techniques
May be required to perform shift work to support operational needs
Minimum Required Qualifications:
Bachelor's degree in a Scientific discipline
Some experience with GMPs, safety regulations, and data integrity
Some experience with analytical methods and related instrumentation
Preferred / Nice to Have Qualifications:
2 years of industry experience is a plus
Knowledge of DLS (Dynamic Light Scattering) testing
GLIMS LabWare and Empower experience
Knowledge of Flow Cytometer
Quantitative and Qualitative PCR experience
Trackwise and SAP experience
Adherent Cell Culture experience
Molecular and cell-based assay experience
Technical writing skills
Pay rate that is commensurate with their level of experience.